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HeartSee version 3 software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in ml/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images and quantification of their severity.

HeartSee version 3 is intended for use by trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data.

HeartSee version 3 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected or known coronary artery disease. HeartSee version 3 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification.

HeartSee version 3 contains two fundamental components. First, the software imports cardiac PET images in DICOM format from PET scanners with DICOM output. These images are reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. Second, the HeartSee version 3 software quantifies regional absolute rest and stress myocardial perfusion per unit tissue (ml/min/q), Coronary Flow Reserve (CFR) as the stress/rest perfusion ratio, and the Coronary Flow Capacity combining CFR and stress perfusion, all on a pixel basis for regional and global values, Archiving output data is supported for clinical diagnostics, quality control and research.

In addition to these established measurements of perfusion in ml/min/g, CFR and CFC approved by FDA for K171303, HeartSee version 3 has the following additional clinically relevant displays. For explaining uncommon patients with angina or ST depression ≥1mm during stress PET imaging in the absence of severe perfusion defects, HeartSee version 3 has the following three additional displays:

• 1. Stress subendocardial to subepicardial ratio on relative activity tomograms.
• 2. Subendocardial stress to rest ratio on relative activity tomograms
• 3. Stress relative topogram maps expressed as a fraction of maximum ml/min/g and called relative stress flow (RSF).

This K202679 submission describes the HeartSee version 3 software, which is an update to the previously cleared HeartSee version 2 (K171303). The new version adds three new displays. The performance data presented focuses on demonstrating that HeartSee version 3 is at least as safe and effective as its predicate device and that the new displays provide additional clinical relevance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal acceptance criteria in numerical values for this 510(k). Instead, it relies on demonstrating equivalence to the predicate device for existing functionalities and clinical relevance for the new functionalities. The performance is reported in terms of statistical associations.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set. It mentions "patients with suspected or known coronary artery disease (CAD)" and "uncommon patients with angina or ST depression ≥1mm during stress PET imaging".

The data provenance is not specified in terms of country of origin. The study appears to be retrospective as it analyzes associations with past clinical events (MACE, mortality) and existing patient characteristics (angina, ST depression).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide information regarding the number of experts or their qualifications for establishing ground truth for any test set or for interpreting the data used in the analysis.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or presented in this document. The study focuses on the algorithm's performance in terms of statistical associations rather than human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented is for the standalone algorithm. The analyses performed (Cox multivariate analysis, Kaplan-Meier plots, ROC analysis, paired t-tests) evaluate the metrics generated by the HeartSee version 3 software directly against clinical outcomes or events, independent of human interpretation of those metrics during the study. The device is intended to "assist clinical interpretation," and the clinician "remains ultimately responsible," but the performance data presented is on the software's outputs themselves.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation includes:

• Outcomes Data:
  • Major Adverse Coronary Events (MACE)
  • Mortality
  • Reduction in MACE/mortality after revascularization
• Clinical Events/Characteristics:
  • Angina during stress PET imaging
  • ST depression ≥1mm during stress PET imaging

8. The Sample Size for the Training Set

The document does not include information about a specific training set or its sample size. This submission appears to be evaluating the performance of an existing or updated algorithm, rather than describing the development and training of a new model.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly described, there is no information on how ground truth for a training set was established.

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HeartSee K171303 Software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images by quantification of their severity.

HeartSee K171303 is intended for use by trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data.

HeartSee K171303 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/q, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected ot known coronary artery disease. HeartSee K171303 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification.

HeartSee contains two fundamental components. First, the software imports cardiac PET images in DICOM format from PET scanners with DICOM output. These images are reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. Second, the K171303 software quantifies absolute rest and stress myocardial perfusion per unit tissue (cc/min/g), Coronary Flow Reserve (CFR) as the stress/rest perfusion ratio and the Coronary Flow Capacity combining CFR and stress perfusion, all on a pixel basis for regional and global values. Archiving output data is supported for clinical diagnostics, quality control and research.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating that K171303 performs "identically" to the predicate device (K143664) for certain metrics and "better" for others.

2. Sample size used for the test set and the data provenance

• Sample Size: 4188 rest and 4188 stress PET perfusion scans.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the data was retrospective or prospective. However, given that the study is comparing performance of two software versions on an existing dataset, it's highly likely to be retrospective analysis of previously acquired patient scans.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts used to establish the ground truth or their qualifications. The study primarily focuses on the algorithmic output against its predicate and clinical association, rather than expert-derived ground truth for individual scan features.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set. The comparison is between the outputs of two software versions (K171303 and K143664) and their statistical association with clinical outcomes, not against a consensus-based ground truth adjudicated by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study focused on human reader improvement with and without AI assistance was not done or reported in this summary. The study reported here is a direct comparison of two algorithmic software versions (K171303 vs. K143664) and their association with clinical outcomes.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone (algorithm-only) performance study was done. The entire summary describes the performance of the K171303 software in processing PET scans and generating quantitative values and maps, implicitly comparing it to the K143664 software, also in a standalone manner. The clinical associations are derived from these algorithmic outputs without explicitly evaluating human-in-the-loop performance.

7. The type of ground truth used

The ground truth used for performance evaluation appears to be:

• Algorithmic equivalence: For the quantitative measurements (perfusion, CFR), the ground truth for K171303's accuracy is its identical output to the predicate K143664.
• Outcomes data: For the clinical associations (MACE, reduced death and MI after revascularization), the ground truth is the actual patient outcomes.

8. The sample size for the training set

The document does not specify the sample size for the training set. It describes a "study" involving the analysis of 4188 rest and 4188 stress PET perfusion scans, which serves as the test set for comparison between K171303 and K143664. It is not clear if these scans were also part of a training set, or if an entirely separate training set was used for developing the software versions. Given the explanation of K171303 being "identical" in code to K143664 with the addition of the CFC map, it's plausible that the core algorithms were developed using separate data, and these 4188 scans validate the outputs and the new CFC map's utility.

9. How the ground truth for the training set was established

Since the document does not specify the training set sample size, it also does not detail how the ground truth for any training set was established.

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